Breast Cancer continues to be the second leading cause of death for women between the ages of 40 to 55 in America. The number of women developing breast cancer has increased tremendously from 1:20 in 1960 to 1:7 today. Epidemiological studies estimate that one in eight women will develop breast cancer during their lifetimes. Moreover, one in five women with breast cancer will die of the disease despite the considerable advances in treatment. According to the American Cancer Society, in 2007, an estimated 178,480 new cases and 40,460 deaths from breast cancer in women are expected to occur in the United States. Given these circumstances, early detection of breast cancer is considered an important prognostic factor, and it has aptly suggested that death from malignancy rather than its detection should be the point of reference in evaluating any screening program.
Breast cancer occurs when cells in the breast begin to grow out of control and can invade nearby tissues or spread throughout the body. It is one of the leading causes of cancer death in women. Cancer development appears to generate an increase in the temperature on the breast surface. There are limitations of mammography as a screening modality, especially in young women with dense breasts and therefore there is a need to develop of novel and more effective screening strategies with a high sensitivity and specificity.
For several decades medical researchers around the world have struggled to find an accurate method for unraveling the nuances of the interpretation of thermal circadian data related to tumor growth in the breast as a detection modality. It has been felt by many researchers that cracking the thermal data code of the breast's minute incremental changes in the breast's temperatures which take place over a twenty-four hour period are direct reflections of the breast's physiological activity and tumor growth.
Currently, mammography is considered the gold standard as a screening tool for the early detection of breast cancer. Unfortunately, it is a standard that does not always shine brightly, for wide variations exist in its sensitivity and specificity in published reports. Mammographic sensitivity varied from 100% in fatty breasts to 4% in extremely dense breasts, as evidenced by a recent study. Moreover, its limitations in young and premenopausal women with dense breast tissue strengthen the need to develop new modalities for the early detection of breast cancer, especially in this group of vulnerable patients. To this end, magnetic resonance imaging (MRI) has been shown to be more sensitive in the early detection of occult breast cancers, particularly in pre-menopausal women for whom the sensitivity of mammography is compromised, but with less specificity. Additional modalities are still under development, such as electrical impedance scanning (EIS), mammary ductoscopy (MD) and proteomics of nipple aspirate fluid (NAF) and serum. In spite of these advances women in the United States are subjected to a million unnecessary breast biopsies each year, because of the inadequacies of the aforementioned breast cancer detection modalities' inability to separate benign from cancerous lesions.
It is known that the establishment and growth of most tumors depend on the successful recruitment of new blood vessels into and around the tumor cells. This latter process, also known as angiogenesis, is dependent on the production of angiogenic growth factors by the tumor cells. Because these new vessels lack smooth muscle fibers rendering them unreceptive to control by hormone control, a more constant blood flow to the area increases the local temperature in the area surrounding the tumor than found in normal breast tissue.
It is recognized that the breast exhibits a circadian rhythm that is reflective of its physiology. The relationship between breast skin temperature and breast cancer has been documented and it is found that the differences between the characteristics of rhythmic changes in skin temperature of clinically healthy and cancerous breasts were real and measurable.
The superficial thermal patterns measured on the surface of the breast are most likely related to tissue metabolism and visualization within the underlying tissue. Such thermal patterns change significantly as a result of normal phenomena including the menstrual cycle, pregnancy and, more importantly, the pathologic process itself. Additionally, it is generally stated that cancer development, in most instances, represents the summation of a large number of mutations that occur over years, each with its own particular histologic phenotype that can be seen in pre-menopausal mastectomy specimens. Cancer development appears to generate its own thermal signatures, and the complexity or lack thereof may be a reflection of its degree of development.
Radiologists fail to detect cancer in up to thirty percent of patients with breast cancer. Also, the malignancies missed by the radiologists are evident in two thirds of the mammograms. There is a need to further assist radiologists, surgeons and other physicians in detecting, diagnosing, successfully biopsing and operating on precancerous and cancerous conditions.
It is known that areas of mammalian tissue adjacent to carcinomas exhibit increased temperature from that exhibited contemporaneously by non-adjacent, non-cancerous areas. The temperature of the cancer-affected areas can fluctuate several degrees Centigrade from normal tissue; these differences having been demonstrated while monitoring such areas for a 24-hour period (one circadian cycle).
One prior device used for detecting cancer is a brassiere which includes a plurality of temperature sensors, an analog multiplexer circuit, a control circuit, a sample and hold circuit, an analog/digital converter, a buffer register, a storage register, a clock and a data logger. The device allows for the storage of temperature readings in a digital form. This digital data may be uploaded to the data logger which converts the digital signals to decimal form so that the temperature differences may be read and analyzed by a supervising physician and the problems associated with such devices are stated in commonly owned U.S. Pat. No. 6,389,305.
Other devices use a passive thermographic analytical apparatus provide a direct readout of the results through analysis of a thermographic radiation pattern of the human body. As previously recognized, such devices are unable to detect small tumors on the order of less than 0.5 cm and possibly other larger tumors as well, especially certain types of cancers and do not take into account the chaotic fluctuation of normal body temperatures over time and between locations on the body.
As previously mentioned, one common and widely used technique for determining existence of breast cancer is mammography. This radiological technique is invasive and not desirable. Most cancer is diagnosed too late and successful diagnosis and treatment are more attainable if the cancer is found at early stages. Other commonly owned devices as described in U.S. Pat. Nos. 6,389,305, 5,941,832, 5,301,681 have met with some limited success, but have yet to provide an optimal breast cancer detection device. There remains a need to improve the method and device for detection of potentially cancerous conditions in breasts.
By virtue of the instant invention, an understanding of the pathological observations and recent technological advances have facilitated the recording of these thermal circadian rhythm variations of the breast in a manner which renders an improved and useful breast cancer detection device.
Recently new modalities, such as magnetic resonance imaging (MRI), have been shown to be more sensitive in the early detection of occult breast cancers, particularly in premenopausal women in whom the sensitivity of mammography is compromised. In the recent reports, MRI is able to detect cancer in the contralateral breast that were missed by mammography or in clinical examination at the time of the initial breast examination. In addition, MRI has proved to be a better screening tool for women with genetic mutations in BRCA1 or BRCA2 genes, and in those women with a strong family history of breast cancer. Although the sensitivity of MRI is better than that of mammography, the technique is flawed by a lower specificity and a far greater expense. However, recently, the American Cancer Society announced a change in its breast cancer screening recommendation guidelines, recommending that women with high genetic risk (such as those who have mutation in the BRCA1 or BRCA2 genes or those with a strong family history of breast cancer) be screened with magnetic resonance imaging.
The breast has been recognized to exhibit circadian rhythms which are reflections of its underlying physiology. There now exist a body of evidence that these rhythms associated with malignant cell proliferation are largely non-circadian. Others have examined the relationship between breast skin temperature and breast cancer as well as the differences between the characteristics in circadian rhythm changes in skin temperature data of clinically healthy and cancerous breasts and found that these changes were both definitely real and measurable.
Thermographic technology was originally introduced to complement mammography, because it was felt that a thermogram of the breast was able to detect early breast cancer development up to 10 years earlier than with most conventional modalities. However, the accuracy of thermography has remained questionable since several factors, such as the symmetry and stability of the breasts' temperature during the menstrual cycle and the use of oral contraception, have been confusing factors.
Presently, there is no ideal technique used to evaluate the results of all methods of early breast cancer detection. Studies on the use of a feasible and non invasive dynamic thermal analysis have been carried out and reported to be sensitive in detection of breast cancer. These were further enhancements with the use of the artificial neural network systems to implement a more effective thermal analysis tool. This tool had shown potential by obtaining almost 85% of sensitivity and specificity. Further studies and improvements were required to reassess this thermal analysis tool, as it may provide promising and significant contributions to the medical and research areas.
The aim of this invention is to use multiple artificial intelligence systems that analyze additional discrete thermal data points collected over a protracted period of time rather than static thermal information is more accurate and useful than current breast cancer detection modalities. This invention demonstrates the use of multiple interpretive systems bring its capabilities within the 90% specificity and sensitivity.